|Publication number||US6893403 B2|
|Application number||US 10/374,240|
|Publication date||May 17, 2005|
|Filing date||Feb 25, 2003|
|Priority date||Feb 25, 2003|
|Also published as||US7311669, US20040167411, US20050187483|
|Publication number||10374240, 374240, US 6893403 B2, US 6893403B2, US-B2-6893403, US6893403 B2, US6893403B2|
|Inventors||Sai Kolluri, Lawrence T. Hersh, Richard Medero|
|Original Assignee||Ge Medical Systems Information Technologies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (17), Referenced by (5), Classifications (5), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The field of the invention is patient monitoring systems. More particularly, the invention relates to an improved patient monitoring method and system using pattern recognition techniques to eliminate noise points in an oscillometric envelope.
The heart muscles of humans periodically contract to force blood through the arteries. As a result of this pumping action, pressure pulses or oscillations exist in these arteries and cause them to cyclically change volume. The baseline pressure for these pulses is known as the diastolic pressure and the peak pressure for these pulses is known as the systolic pressure. A further pressure value, known as the “mean arterial pressure” (MAP), represents a time-weighted average of the blood pressure.
There are different techniques and devices for measuring one or more of these blood pressure values. One method in particular involves applying a pressure cuff about the upper arm of a human and inflating it above systolic pressure so as to restrict the flow of blood in the brachial artery. The pressure is then slowly relieved while a stethoscope is used on the distal portion of the artery to listen for pulsating sounds, known as Korotkoff sounds, that accompany the reestablishment of blood flow in the artery. As the pressure in the cuff is reduced further, the Korotkoff sounds eventually disappear. The cuff pressure at which the Korotkoff sounds first appear during deflation of the cuff is an indirect measure of the systolic pressure and the pressure at which these sounds disappear is an indirect measure of the diastolic pressure. This method of blood pressure detection is generally known as the auscultatory method.
Another method of measuring blood pressure is referred to as the oscillometric technique. This method of measuring blood pressure involves applying an inflatable cuff around an extremity of a patient's body, such as the patient's upper arm. The cuff is then inflated to a pressure above the patient's systolic pressure and then incrementally reduced in a series of small steps (or continuously at a substantially constant rate). A pressure sensor measures the cuff pressure throughout the blood pressure determination. The sensitivity of the sensor is such that pressure fluctuations within the cuff resulting from the beats of the patient's heart may be detected. With each beat there is a resulting small change in the artery volume which is transferred to the inflated cuff causing slight pressure variations within the cuff which are detected by the pressure sensor. The pressure sensor produces an electrical signal showing the incremental cuff pressure and a series of small periodic variations associated with the beats of a patient's heart. It has been found that these variations, called “complexes” or “oscillations,” have a peak-to-peak amplitude which is minimal for applied cuff pressures above the systolic pressure. As the cuff pressure is decreased, the oscillation size begins to monotonically grow and eventually reaches a maximum amplitude. After the oscillation size reaches the maximum amplitude, the oscillation size decreases monotonically as the cuff pressure continues to decrease. Oscillometric envelope data such as this is often described to as having a “bell curve” appearance. Physiologically, the cuff pressure at the maximum value approximates the MAP. In addition, the complex amplitudes of cuff pressures equivalent to the systolic and diastolic pressures have a fixed relationship to this maximum value. Thus, the oscillometric method is based on measurements of detected complex amplitudes at various cuff pressures.
Blood pressure measuring devices operating according to the oscillometric method detect the peak-to-peak amplitude of the pressure complexes at the various applied cuff pressure levels. The amplitudes of these complexes, as well as the applied cuff pressure, are stored together as the device automatically changes the cuff pressures over a range of interest. These peak-to-peak complex amplitudes define an oscillometric “envelope” and are evaluated to find the maximum value and its related cuff pressure, which is approximately equal to MAP. The cuff pressure below the MAP value which produces a peak-to-peak complex amplitude having a certain fixed relationship to the maximum value is designated as the diastolic pressure. Likewise, the cuff pressure above the MAP value which results in complexes having an amplitude with a certain fixed relationship to that maximum value is designated as the systolic pressure. The relationships of complex amplitude at systolic and diastolic pressures, respectively, to the maximum value, are empirically derived ratios which assume varying levels depending on the preferences of those of ordinary skill in the art. Generally, these ratios are designated in the range of 40% to 80%.
One way to determine oscillation magnitudes is to computationally fit a curve to the oscillometric envelope defined by complex amplitude data points which are measured by a blood pressure monitor at varying cuff pressures. The fitted curve may then be used to compute an approximation of the MAP data point, which is approximately at the maximum value of the fitted curve and is therefore easily determined by computing the point on the fitted curve in which the first derivative equals zero. From this maximum value data point, the systolic and diastolic pressures may be computed as fixed percentages of the maximum value. In this manner, the systolic data point and the diastolic data point along the fitted curve may each be computed and therefore their respective pressures may also be determined. This curve fitting technique has the advantage of filtering or smoothing the oscillometric envelope. However, in some circumstances it has been found that additional filtering techniques used on the oscillometric envelope can improve the accuracy of the resulting blood pressure values.
The reliability and repeatability of blood pressure computations hinges on the ability to accurately determine the oscillation magnitudes of the complexes. There are several barriers to accurate and reliable oscillation magnitude determination. First, artifacts caused by patient motion and other effects are often present. These artifacts are superimposed upon the desired oscillation signal, causing it to be distorted. Second, many of the properties of the desired oscillation signal are not consistent from patient to patient, or even from oscillation to oscillation for a given patient. Because of these types of potentially adverse effects on the oscillometric signals, most automatic blood pressure instruments look for a consistency in pulses at a particular pressure level. For example, before a complex is accepted as adequate for use in the determination of blood pressure, there may be a requirement for consistency in pulse size compared to other pulses at the same step, adjacent steps, or previous determinations at the same pressure level. Further, there may be requirements on the consistency of pulse periods before a pulse is accepted as adequate for use in a blood pressure determination.
Despite significant signal processing efforts, artifact corrupted complexes are sometimes used in blood pressure calculations. Oftentimes, these complexes are of such an energy level that they unduly influence the curve fit smoothing technique. Thus, there exists a need for a method and system for effectively using pattern recognition techniques to eliminate noise or physiologically unimportant points in oscillometric envelope data before it is used in calculating blood pressure.
One embodiment of the present invention provides a method of rejecting artifacts in oscillometric envelope blood pressure data including evaluating conformance of the oscillometric envelope blood pressure data with a predetermined expected pattern. In addition, the method includes excluding one or more data points of the oscillometric envelope blood pressure data based on non-conformance with the expected pattern.
Another embodiment of the present invention provides a method of rejecting artifacts in oscillometric envelope blood pressure data including evaluating conformance of the oscillometric envelope blood pressure data with previous blood pressure data that meets acquisition time requirements. In addition, the method includes excluding one or more data points of the oscillometric envelope blood pressure data based on non-conformance with the previous blood pressure data.
Another embodiment of the present invention provides a method of rejecting artifacts in oscillometric envelope data including storing data for a plurality of blood pressure data points, including acquisition time. In addition, the method includes removing a blood pressure data point having an earliest acquisition time from the oscillometric envelope blood pressure data and reacquiring the data.
Another embodiment of the present invention provides a method of rejecting artifacts in oscillometric envelope data including applying a curvefit to the oscillometric envelope blood pressure data, measuring a quality of deviation of the oscillometric envelope blood pressure data from the curvefit and comparing the quality of deviation of the oscillometric envelope blood pressure data to an allowed threshold. In addition, the method includes removing a data point where the quality of deviation for that data point exceeds the allowed threshold.
Another embodiment of the present invention provides an apparatus for measuring blood pressure including an inflatable cuff, a pressurizing apparatus, a cuff pressure sensor, and a programmed control device. The pressurizing apparatus is coupled to the cuff for selectively applying pressure by inflating or deflating the cuff. The cuff pressure sensor is coupled to the cuff for sensing cuff pressure and blood pressure oscillations. Further, the programmed control device functions to control the pressure cuff and pressurizing apparatus, evaluate conformance of the blood pressure oscillations with a predetermined expected pattern, and exclude one or more data points of the blood pressure oscillations based on non-conformance with the expected pattern.
Another embodiment of the present invention provides a system for rejecting artifacts in oscillometric envelope blood pressure data including a means for evaluating conformance of the oscillometric envelope blood pressure data with a predetermined expected pattern and a means for excluding one or more data points of the oscillometric envelope blood pressure data based on non-conformance with the expected pattern.
Another embodiment of the present invention provides a computer program product including a computer useable medium having computer logic for enabling at least one processor in a computer system to reject artifacts in oscillometric envelope blood pressure data. In addition, the computer program product includes a means for evaluating conformance of the oscillometric envelope blood pressure data with a predetermined expected pattern and a means for excluding one or more data points of the oscillometric envelope blood pressure data based on non-conformance with the expected pattern.
A pressure transducer 104 is coupled by a tube or duct 105 to the cuff 101 for sensing the pressure therein. In accordance with conventional oscillometric techniques, pressure oscillations in the artery are sensed by changes in the counter-pressure of the cuff 101, and these pressure oscillations are converted into an electrical signal by transducer 104 and coupled over path 106 to microprocessor 107 for processing. In addition, a source of pressurized air 109 is connected via a duct 110 through an inflate valve 111 and a duct 112 to the pressure cuff 101. The inflate valve 111 is electrically controlled through a connection 113 from the microprocessor 107. Also, the deflate valve 102 is connected by duct 114 via a branch connection 115 with the duct 112 leading to cuff 101.
Local maxima are indicated by points that create significant vertexes, apexes, humps, peaks, rises, etc. on the oscillometric envelope relative to the other data points. They typically can be determined mathematically or through other similar methods. At step 206, it is determined whether the number of local maxima is greater than one. If the number is greater than one, then the maximum amplitude point on the first local maxima (closer to the systolic side of the envelope) is removed at step 208. Then, the number of local maxima is once again determined at step 210. If the number of local maxima is greater than one at step 212, then the previous maximum amplitude point that was removed at step 208 is added back into the data at step 214. In addition, the maximum amplitude point on the second local maxima is removed at step 214. Once the point is removed, the number of local maxima is once again determined at step 216. If the number is greater than one at step 218, the previous maxima that was eliminated is added back to the data at step 220. If the number of local maxima is not greater than one at steps 206, 212, 218, then the process for removing extraneous data points from the oscillometric envelope based on pattern recognition techniques proceeds to the process shown in FIG. 3.
It should be noted that each of the steps described above with regard to
Process 300 begins by finding the number of points on the systolic side of the data at step 302. At step 304, the process determines whether the number of points on the systolic side of the data is greater than two. If the number is greater than two, the process identifies the number of points on the systolic side that are less than 20% of the MAP amplitude at step 306. While this example uses the value equal to 20% of the MAP amplitude, other values may be used. For example, values that are close to 20% (e.g., 15% 18%, 23%, 25%, etc.) may also be used. At step 308, the process determines whether the number of these points is greater than two. If so, it is possible that the signal at the MAP may be noise since it is unlikely that a large number of the systolic data points are less than 20% of the MAP. Consequently, the maximum amplitude point is eliminated from the data at step 310. However, if the number of points at steps 304 and 308 are not greater than two, the process for removing data points from oscillometric envelopes proceeds to FIG. 4A.
If the number of points from step 406 is equal to two or more, points are also selectively obtained from the diastolic side at step 412 by including two points that are greater than 30% of the MAP amplitude. At least one point should be included that is less than 60% of the MAP amplitude at step 412. After the points are taken out of the data at steps 410, 412, the number of points on the diastolic side are determined at step 414. Whether the number of points on the diastolic side is less than two is determined at step 416. If the number of points is less than two, more data is collected on the diastolic side at step 418 and the entire evaluation process is repeated. If the number of points is equal to two or more, the algorithm proceeds to FIG. 5.
for local minima, or it is determined whether
for local maxima. For these determinations, amp[i] is simply the mm of Hg as a measure of amplitude for a particular point on the oscillometric envelope. Thus, amp[i+1] and amp[i+2] are amplitudes for subsequent points along the envelope. If the conditions of step 606 are satisfied, the data point amp[i+1] is considered a local extreme at step 608. Step 610 takes the next data point after either finding a local extreme at step 608 or not meeting any conditions at step 606. From the next data point, the process determines whether there are any more data points at step 612. If there are more data points, the process determines whether the curve direction is generally upward. If so, the process returns back to step 606 to analyze the next data points relative to one another. If there are not any more data points at step 612, the process is finished at step 626. If the curve direction is not generally upward, but is instead downward, the determination is made whether
for local maxima or
for local minima at step 616. If these conditions of step 616 are met, the curve direction is changed at step 618 for detection of other local extremes. If the conditions of step 616 are not met, the analysis proceeds to the next amplitude point on the envelope at step 620. At step 622, it is determined whether there are any more data points. If so, the process determines whether the curve direction is generally downward at step 624. If the direction is downward, the process returns to step 616. If the direction is not downward, the process returns to step 606. If there are no more data points at step 622, the process of
where error is absolute error, curvefit is an amplitude derived from a curvefit of envelope data at a same pressure that corresponds to the raw data, and raw data are measured envelope data points. Next, the quality of deviation is computed for each raw data point at step 908. In computing the quality of deviation (Qdev), the following equation may be used:
where Qdev is quality of deviation, error is error previously determined, and raw complex amplitude are data point(s) used. Whether Qdev is less than the threshold for any of the data points is determined at step 910. If so, the data point is removed and a new data point is reacquired for that point (if necessary) at step 912. Then the process returns to step 904 to apply a curvefit to the remaining oscillometric envelope data points. If Qdev is less than the threshold for all of the data points at step 910, the pattern is qualified to compute blood pressure at step 914. It is important to note that the threshold can be any number of different values as required for a particular situation or as is generally accepted within the art.
While the embodiments and application of the invention illustrated in the figures and described above are presently preferred, it should be understood that these embodiments are offered by way of example only. Accordingly, the present invention is not limited to a particular embodiment, but extends to various modifications that nevertheless fall within the scope of this application.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4360029||Oct 3, 1980||Nov 23, 1982||Johnson & Johnson||Automatic mean blood pressure reading device|
|US4543962||Jul 9, 1984||Oct 1, 1985||Critikon, Inc.||Method of automated blood pressure detection|
|US4638810||Jul 5, 1985||Jan 27, 1987||Critikon, Inc.||Automated diastolic blood pressure monitor with data enhancement|
|US4729383 *||Dec 7, 1984||Mar 8, 1988||Susi Roger E||Method and apparatus for automatically determining blood pressure measurements|
|US4796184||Aug 1, 1986||Jan 3, 1989||Cas Medical Systems, Inc.||Automatic blood pressure measuring device and method|
|US4889133||May 25, 1988||Dec 26, 1989||Protocol Systems, Inc.||Method for noninvasive blood-pressure measurement by evaluation of waveform-specific area data|
|US4949710||Oct 6, 1988||Aug 21, 1990||Protocol Systems, Inc.||Method of artifact rejection for noninvasive blood-pressure measurement by prediction and adjustment of blood-pressure data|
|US5054494 *||Dec 26, 1989||Oct 8, 1991||U.S. Medical Corporation||Oscillometric blood pressure device|
|US5505206 *||Jul 22, 1993||Apr 9, 1996||Spacelabs Medical, Inc.||Method and apparatus for excluding artifacts from automatic blood pressure measurements|
|US5542428 *||Mar 23, 1995||Aug 6, 1996||Spacelabs Medical, Inc.||Method and apparatus for removing artifact encountered during automatic blood pressure measurements|
|US5579776||Jan 13, 1995||Dec 3, 1996||Johnson & Johnson Medical, Inc.||Oscillometric blood pressure monitor with enhanced cuff pressure control|
|US5590662 *||Feb 15, 1995||Jan 7, 1997||Johnson & Johnson Medical, Inc.||Detection of oscillometric blood pressure complexes using correlation|
|US5704362||Aug 13, 1993||Jan 6, 1998||Johnson & Johnson Medical, Inc.||Method for oscillometric blood pressure determination employing curve fitting|
|US6358213 *||Aug 18, 1999||Mar 19, 2002||Critikon Company, Llc||Calculation of quality and its use in determination of indirect noninvasive blood pressure|
|US6423010||Oct 4, 2000||Jul 23, 2002||Critikon Company, L.L.C.||Oscillometric blood pressure monitor with improved performance in the presence of arrhythmias|
|US6440080||Sep 25, 2001||Aug 27, 2002||Ge Medical Systems Information Technologies, Inc.||Automatic oscillometric apparatus and method for measuring blood pressure|
|US20020082507||Mar 1, 2002||Jun 27, 2002||Sai Kolluri||Physiological-signal-analysis device for measuring a blood pressure and method|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7544167 *||Jan 23, 2007||Jun 9, 2009||Ge Medical Systems Information Technologies, Inc.||Method and system for cuff pressure reversions|
|US8114026||Jun 22, 2010||Feb 14, 2012||Infarct Reduction Technologies Inc.||Methods and devices for remote ischemic preconditioning and near-continuous blood pressure monitoring|
|US8652055 *||Jun 2, 2011||Feb 18, 2014||Shisei Datum Co., Ltd.||Electronic hemomanometer, method of correcting pulse wave data of electronic hemomanometer, program for causing a computer to execute procedures and computer-readable recording medium|
|CN102894964A *||Jul 26, 2011||Jan 30, 2013||深圳大学||Method and device for non-invasively measuring blood pressure|
|CN102894964B||Jul 26, 2011||Aug 20, 2014||深圳大学||Method and device for non-invasively measuring blood pressure|
|U.S. Classification||600/494, 600/496|
|Apr 22, 2003||AS||Assignment|
|Oct 1, 2008||FPAY||Fee payment|
Year of fee payment: 4
|Dec 31, 2012||REMI||Maintenance fee reminder mailed|
|May 17, 2013||LAPS||Lapse for failure to pay maintenance fees|
|Jul 9, 2013||FP||Expired due to failure to pay maintenance fee|
Effective date: 20130517